FDA opioid crackdown: Should pharma companies be worried?

By Health Care FOXBusiness

(AP)

The Food and Drug administration is stepping up efforts to curb opioid addiction in the United States, making the unprecedented decision this week to ask a pharmaceutical company to remove an advertised opioid drug from the market.

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The FDA on Thursday requested that Endo Pharmaceuticals (ENDP) cease sales of Opana ER, an around the clock pain medication that was approved for sale in 2006, due to the risk of patient abuse. The agency said it determined the benefits of the drug no longer outweigh the risks.

“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Scott Gottlieb said in a statement Thursday.

Dr. Gottlieb, who was nominated by President Donald Trump in March, said late last month he would use every tool legally available to him to “ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients,” in a blog post on the FDA’s website. 

The Trump administration has emphasized the urgency of the problem and established a commission, led by Gov. Chris Christie (R-N.J.), to combat it – a combination of factors that may have encouraged the FDA’s recent decision.

“[The Trump administration and Dr. Gottlieb] clearly have taken [opioid addiction] on, and I think that pushed the FDA … with the change in the administration and a new commissioner and specifically a public announcement [from the FDA],” said Larry Stevens, a former FDA official and current FDA Group consultant, in an interview with FOX Business.

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The Centers for Disease Control report deaths from prescription opioids have more than quadrupled in the United States since 1999 and sales of the pain medication throughout the same period have increased by the same amount, while the volume of pain reported by Americans has not changed. More than 90 Americans die each day from an opioid overdose, according to the CDC, which amounts to at least 33,000 fatalities each year.

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As the epidemic rages on, could more pain relievers suffer a similar fate to Opana ER?

“The problem that the FDA has is that these drugs have proven to be very effective in the relief of pain,” Stevens said, pointing out that until manufacturers create a drug that is effective but cannot be abused, they will likely continue to be available on the market.

While the FDA said in a statement that it cannot speculate at this time what action it may take "in regard to other specific opioid products," it "will take steps to remove a drug from the market when the FDA is concerned that a drug’s risks now outweigh its benefits."

Former FDA commissioner Mark McClellan said drug companies should definitely take the FDA's most recent decision as a sign of action to come.

“[There will be] more coming to address opioid abuse from the FDA, really focusing on the personal risks and benefits,” McClellan told FOX Business. "[The Opana ER decision] is a good road map for how the FDA is now considering [the effects of these drugs]."

Endo Pharmaceuticals issued a statement Thursday, saying it was “reviewing the request” and “evaluating the full range of potential options,” while pushing back against the claim the drug is more dangerous than helpful. The company is under no legal obligation at this point to comply with the FDA’s request.

“Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients,” a company statement said Thursday.

Investors did not take the news lightly. Endo’s stock plunged more than 14 percent during the trading session Friday.

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